FDA 510(k) Application Details - K123565

Device Classification Name	System, Imaging, Pulsed Doppler, Ultrasonic   More FDA Info for this Device
510(K) Number	K123565
Device Name	System, Imaging, Pulsed Doppler, Ultrasonic
Applicant	PHYSIOSONICS, INC 2002 156TH AVE, NE, SUITE 150 MCKINLEY BUILDING BELLEVUE, WA 98007 US Other 510(k) Applications for this Company
Contact	DAVID CRONISER Other 510(k) Applications for this Contact
Regulation Number	892.1550   More FDA Info for this Regulation Number
Classification Product Code	IYN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/20/2012
Decision Date	12/13/2012
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review